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Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Bicalutamide (Drug); Dutasteride (Drug); Finasteride (Drug); Radiation (Radiation)

Phase: N/A

Status: Recruiting

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Stanley Liauw, MD, Principal Investigator, Affiliation: University of Chicago


The purpose of this study is see if quality of life is improved in patients receiving oral hormone therapy compared to standard of care. The study will also compare survival rates between patients receiving oral hormone therapy and those receiving standard of care.

Clinical Details

Official title: A Feasibility Study of Oral Hormonal Therapy and Radiation for Non-metastatic, Intermediate or High Risk Prostate Cancer in Men 70 and Older or With Medical Comorbidities

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Quality of Life

Secondary outcome: Progression Free Survival


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


Inclusion Criteria:

- Age > or = 70 years and/or Charlson comorbidity index score > or = 2

- Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma

- Two or more of the following intermediate risk features for recurrence, Gleason Score

= 7, PSA 10-20 ng/ml, Clinical Stage T2b-T2c Percent positive biopsy cores > or = 50%

- One or more of the following high risk features for recurrence, Gleason Score 8-10,

PSA > 20 ng/ml, Clinical Stage T3a-T4

- Clinically negative lymph nodes as established by imaging, nodal sampling, or


- No evidence of bone metastases on bone scan

- History/physical examination via the Charlson Comorbidity Index within 60 days prior

to registration

- Zubrod Performance Status 0-2

- Age > or = 18

- Baseline serum PSA within 60 days prior to registration

- Baseline serum testosterone obtained within 60 days prior to registration

- Study entry PSA and serum testosterone must not be obtained during the following time

frames, 10-day period following prostate biopsy, following initiation of oral androgen manipulation, within 30 days after discontinuation of finasteride or dutasteride

- CBC/ differential obtained within 60 days prior to registration with adequate bone

marrow function

- Patient must be able to provide study-specific informed consent prior to study entry

- Liver function parameters as follows, Total Bilirubin < or = 2 x institutional upper

limit of normal, AST (SGOT) or ALT (SGPT) < or = 2 x institutional upper limit normal Exclusion Criteria:

- Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or

cryosurgery for prostate cancer

- Prior hormonal therapy, such as LHRH agonists (e. g., goserelin, leuprolide),

antiandrogens (e. g., flutamide, bicalutamide), estrogens (e. g., DES), or bilateral orchiectomy

- Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically

prescribed for the treatment of prostate cancer

- Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy

for a different cancer is permitted

- Prior radiation, including brachytherapy, to the region of the prostate that would

result in overlap of RT fields

- Active lupus or scleroderma

- Severe, active co-morbidity, including but not limited to,unstable angina within the

last 6 months without subsequent corrective cardiovascular procedure,or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

- Hepatic insufficiency with AST, ALT, or Bilirubin > 2 x upper limit of

normal,clinical jaundice, and/or coagulation defects

- Acquired Immune Deficiency Syndrome (AIDS); note, however, that HIV testing is not

required for entry into this protocol. Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation

Locations and Contacts

University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Kimberly Janko, RN, BSN, Phone: 773-702-2856, Email: kjanko@radonc.uchicago.edu
Additional Information

Starting date: December 2010
Last updated: June 22, 2015

Page last updated: August 23, 2015

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